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Destination: atl_JNS_12551_ Children: Item: Title: 1 INTRODUCTION Destination: HeadingJNS_12551jns12551-sec-0004 Item: Title: 2 MATERIALS AND METHODS Destination: HeadingJNS_12551jns12551-sec-0005 Children: Item: Title: 2.1 Trial design Destination: HeadingJNS_12551jns12551-sec-0006 Item: Title: 2.2 Trial objectives Destination: HeadingJNS_12551jns12551-sec-0007 Children: Item: Title: 2.2.1 Primary objectives Destination: HeadingJNS_12551jns12551-sec-0008 Item: Title: 2.2.2 Secondary objectives Destination: HeadingJNS_12551jns12551-sec-0009 Item: Title: 2.2.3 Exploratory objectives Destination: HeadingJNS_12551jns12551-sec-0010 Item: Title: 2.3 Study population Destination: HeadingJNS_12551jns12551-sec-0011 Children: Item: Title: 2.3.1 Inclusion criteria Destination: HeadingJNS_12551jns12551-sec-0012 Item: Title: 2.3.2 Exclusion criteria Destination: HeadingJNS_12551jns12551-sec-0013 Item: Title: 2.4 Trial intervention Destination: HeadingJNS_12551jns12551-sec-0014 Item: Title: 2.5 Endpoints and outcome assessment Destination: HeadingJNS_12551jns12551-sec-0015 Children: Item: Title: 2.5.1 Primary endpoints Destination: HeadingJNS_12551jns12551-sec-0016 Item: Title: 2.5.2 Secondary endpoints Destination: HeadingJNS_12551jns12551-sec-0017 Item: Title: 2.5.3 Exploratory endpoints Destination: HeadingJNS_12551jns12551-sec-0018 Item: Title: 2.6 Concomitant medications Destination: HeadingJNS_12551jns12551-sec-0019 Item: Title: 2.7 Statistical analysis Destination: HeadingJNS_12551jns12551-sec-0020 Children: Item: Title: 2.7.1 Sample size Destination: HeadingJNS_12551jns12551-sec-0021 Item: Title: 2.7.2 Bayesian analysis Destination: HeadingJNS_12551jns12551-sec-0022 Item: Title: 2.8 Efficacy and safety evaluation Destination: HeadingJNS_12551jns12551-sec-0023 Item: Title: 3 DISCUSSION Destination: HeadingJNS_12551jns12551-sec-0024 Children: Item: Title: 3.1 Addressing feasibility/low recruitment rates Destination: HeadingJNS_12551jns12551-sec-0025 Item: Title: 3.2 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